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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bath, Hydro-Massage
510(k) Number K880355
Device Name MODEL 938 BATHING SYSTEM
Applicant
Ferno Ille-Forge
2245 Reach Rd.
Williamsport,  PA  17701
Applicant Contact DONALD R MILLER
Correspondent
Ferno Ille-Forge
2245 Reach Rd.
Williamsport,  PA  17701
Correspondent Contact DONALD R MILLER
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received01/26/1988
Decision Date 02/16/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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